1. Advertising rules

The rules on advertising of medicinal products appear from Part VII (sections 63-77) of the Danish Medicines Act, Executive Order no. 272 of 21 March 2007 on Advertising *, etc. of Medicinal Products (the Executive Order on Advertising of Medicinal Products) and Executive Order no. 1244 of 12 December 2005 on the Supply of Medicinal Product Samples.

*As amended by Executive Order no. 393 of 27 April 2007.

In Addition, sections 71a-71c of the Danish Medicines Act and section 3b of the Danish Pharmacy Act lay down rules on bonuses and discounts offered in connection with the sale of pharmacy-only medicinal products. These rules are also addressed in these guidelines.

2. Definition of advertising and scope of rules

2.1. Definition and scope

The term advertising is defined in section 1(1) of the Executive Order on Advertising: Advertising means any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.

The definition does not specify that the entity advertising for a medicinal product must have a special interest (typically financial) in promoting the sale of a medicinal product. If a person or company via public communication clearly acts to induce others to buy a certain medicinal product, and such communication appears as advertising in form, this is tantamount to advertising for medicinal products regardless of whether the person or company is acting on own initiative and is fully independent, in law and in fact, from the company holding the marketing authorisation for the product concerned.

The advertising rules apply to all types of medicinal products for human beings and animals, including herbal medicinal products, traditional herbal medicinal products, homeopathic medicinal products and strong vitamin and mineral preparations with the modifications specified in the Danish Medicines Act and the Executive Order on Advertising.

2.2. Exceptions

According to section 2, the following information, etc. is outside the scope of the Executive Order on Advertising:

The labelling and patient information leaflet of the medicinal product, cf. the Executive Order on Labelling.

Correspondence of an individual nature, if required accompanied by documents of a non-commercial nature which serve the purpose of answering specific questions about a certain medicinal product.

Necessary and concrete information or documentation serving safety and non-commercial purposes, e.g. information about changes to the pack, new adverse reactions or errors in the manufacturing process. Safety purposes is to be interpreted broadly so that e.g. instructions on how to open the pack of a medicinal product without damaging the product itself would fall under the term safety purposes as defined in the Executive Order on Advertising.

Price lists, product catalogues, etc. that only contain information about the names and prices of the medicinal products. The publications must not contain information about competing medicinal products.

Information material about health and diseases provided that specific medicinal products are not mentioned neither directly nor indirectly. This could be anything from traditional folders to comprehensive websites.

Patient information leaflets either handed out when a prescriber prescribes a medicinal product to a patient or handed out by a pharmacy in connection with the dispensing of a medicinal product, provided they only contain objective information of significance to the patient and his relatives. The information must comply with the summary of product characteristics.

Press releases providing concise information about a medicinal product, having a general topical value and targeting the press, distributed or made available to a multitude of reporters or media the aim being to obtain a journalistic assessment and preparation before publication. However, if a press release is placed on a company's website which is accessible to the public and it is suited to accelerate prescription, supply, sale or consumption of a certain medicinal product it will be covered by the advertising rules.

Unedited and unabbreviated reproduction of agency approved information about a medicinal product in the form of a patient information leaflet, summary of product characteristics or publicly available assessment report provided that the information is made available in a manner requiring the users to actively search for the information. For example, this would include a company placing a list of product names on its website with a link to the summaries of product characteristics and patient information leaflets for each of the their medicinal products.

Information material about medicinal products that has been prepared by public medical committees with the purpose of promoting rational use of medicines does not fall under the advertising rules. Furthermore, when a company submits scientific articles about clinical trials on medicinal products to health professionals, such material is not considered advertising either, however, provided that the articles do not include additional comments or supplementary material. Such articles must already have been published in an accredited and independent Danish or foreign professional journal, or similar. This also applies to uncommented scientific articles containing results from comparative studies of different medicinal products.

2.3. Health professionals and the public

The advertising rules distinguish between advertising to the public and advertising to health professionals. Health professionals means doctors, dentists, veterinarians, pharmacists, nurses, veterinary nurses and pharmaceutical assistants as well as students within these professions, cf. section 1(3) of the Executive Order on Advertising.

Anyone who is not a health professional is considered to fall under the general public, cf. section 66(2) of the Danish Medicines Act and section 1(2) of the Executive Order on Advertising. There are a few exceptions: Some non-health professionals may in fact be handling medicinal products as part of their profession, e.g. staff in outlets selling non-pharmacy medicinal products, cf. Part VIII of the Executive Order on Advertising. Read more under 4.6 below.

3. General provisions

3.1. General advertising requirements

Section 63 of the Danish Medicines Act lays down the general requirements to content and form of medicine advertising. The provisions apply to both advertising to the public and advertising to health professionals.

First, advertising must be adequate. In other words, an advertisement that does not give incorrect or misleading information is actually not enough. Advertising must contain adequate information so that the recipients are able to understand and assess when and under which circumstances the medicinal product can and ought to be used and when it should not be used.

For example, an advertisement is not adequate if the wording of the advertisement is so broad that it is capable of promoting the consumption of a medicinal product which, in the given situation, would not be appropriate to use.

The provisions that advertising must contain a number of compulsory details, cf. 4.4 and 5.1, are founded on the requirement that advertising of medicinal products must be adequate.

Second, advertising must be objective. This means that medicinal products must not be marketed in a manner as aggressive and consumption generating as that for ordinary consumer goods. A medicinal product advertisement must not be designed to generate or encourage unnecessary consumption of medicinal products.

Third, advertising must not mislead or exaggerate the qualities of a medicinal product. This means that the form and content of advertising must not give users of medicine and persons prescribing or dispensing medicinal products an erroneous belief about the medicinal product concerning the effects, adverse reactions, price, content, etc. of the product. Advertising must not put a medicinal product in a more favourable position than other corresponding and perhaps more suitable medicinal products.

Fourth, the information given in advertising must be compatible with the approved summary of product characteristics. The summary of product characteristics includes information about product composition, pharmaceutical form, indications (what the drug is used for), contraindications, adverse reactions, precautions, dose and warnings, etc.

This means that the factual content of the advertisement must not conflict with the particulars of the summary of product characteristics. However, it is possible to use other phrases provided they stay within the scope of the objectivity requirement.

3.2. Comparative advertising

Advertising that compares a product with other medicinal products (including price comparisons) must clearly indicate which medicinal products, including strengths, pack sizes, etc. are compared, cf. section 16(1) of the Executive Order on Advertising.

Comparisons must only be made in respect of medicinal products, including strengths and pack sizes, which are relevant to compare from an objective point of view, i.e. medicinal products that are used for the same indication, cf. section 16(1) of the Executive Order on Advertising.

It follows from section 63 of the Danish Medicines Act that a comparison is only adequate if it covers all generic (and parallel imported) medicinal products that neither differ in terms of package form, therapeutic form or strength nor differ substantially in terms of pack size. However, medicinal products with an insignificant market share do not need to be included in the comparison.

According to Section 16(2) of the Executive Order on Advertising, comparative advertising must be based on the particulars of the summaries of product characteristics for the medicines concerned.

Section 10(1)(ii), of the Executive Order on Advertising specifies that it is prohibited to give the general public the impression that a medicinal product is better or just as good as the effect of another medicinal product. Consequently, advertising targeting the general public must not compare the effects of several medicinal products, cf. section 16(3) of the Executive Order on Advertising.

3.3. Medicinal products not sold in Denmark

Section 64(i), of the Danish Medicines Act prohibits any advertising of medicinal products that are not legally sold or dispensed in Denmark.

A new medicinal product can only be sold legally after approval and the issue of a marketing authorisation. In addition, anyone placing a pharmacy-restricted medicinal products on the Danish market must quote a medicinal product price to the Danish Medicines Agency no later than 14 days prior to when the price is to take effect, cf. section 77(1) of the Danish Medicines Act. For some non-pharmacy-restricted medicinal products there is also a requirement that the pack sizes in which they are sold must be reported to the Danish Medicines Agency, also at 14 days' notice, cf. section 78(1) of the Danish Medicines Act.

3.4. Magistral medicinal products

Section 64(ii), of the Danish Medicines Act prohibits any advertising of magistral medicinal products. This logically has to do with the fact that magistral medicinal products are prepared for an individual person or animal on instructions from a doctor or veterinarian.

3.5. Special medicinal products

Section 3 (iii) through (v), of the Executive Order on Advertising prohibits the advertising of

medicinal products for non-clinical trials and clinical trials if a marketing authorisation has not been issued for the medicinal products concerned,

medicinal products sold of dispensed according to a special compassionate use permit according to section 29 of the Danish Medicines act, and

sera, vaccines, specific immune globulins and other immunological investigational medicinal products not covered by a marketing authorisation and which are sold or dispensed from Statens Serum Institut or the National Veterinary Institute, Technical University of Denmark in accordance with section 30 of the Danish Medicines Act.

3.6. Keeping records of advertising material

According to section 68(1) and (2), the holder of a marketing authorisation for a medicinal product has a duty to keep a copy of or other documentation for all advertising material related to a medicinal product for at least two years. The marketing authorisation holder must keep a copy of all advertising material regardless of form. The material must be made available to the Danish Medicines Agency on request.

According to section 17(2) of the Executive Order on Advertising, the advertising material must be stored in print or similar form, or digitally in a generally available format, meaning that a printed advertisement can be stored either in paper form, other hardcopy form or digitally. In other words, if an advertisement has been published in various journals, stuck as a poster on a wall or handed out as folder, etc. there is no requirement to store the advertising material in paper form.

A generally available digital format means formats (file types) that are commonly used in Denmark which normally do not cause problems, neither when displaying the content on a computer nor when exchanging it between various parties. Examples include the presentation format PDF (Portable Document Format; suffix:.pdf) as well as the picture formats TIFF (Tagged Image File Format; suffix:.tif or.tiff) and JPEG (Joint Photographics Expert Group; suffix:.jpeg or.jpg).

Apart from the advertisement itself, the holder of a marketing authorisation must keep information about how the advertisement has actually been applied, cf. section 17(3) of the Executive Order on Advertising:

Target group, i.e. the group that the advertisement was aimed at,

Distribution method,

Media list specifying where the advertisement has been displayed,

Period during which the advertisement was displayed.

If a party other than the holder of the marketing authorisation advertises for a medicinal product, the duty to keep a copy of the advertisement material, etc. lies with this other party who is thus responsible for the advertisement. This could be a retail distributor or a parallel distributor.

According to section 68(4) of the Danish Medicines Act, the Danish Medicines Agency is entitled to request disclosure of all necessary information from the party responsible for the advertisement in order to check whether it is lawful.

The provision allows the Danish Medicines Agency to request particulars about a pharmaceutical company's expenses for a professional congress, thus enabling it to check whether the participants have received presents or other financial benefits to an illegal extent, cf. Part VII of the Executive Order on Advertising.

3.7. Orders by the Danish Medicines Agency

As provided by section 69 of the Danish Medicines Act, the Danish Medicines Agency may require that illegal advertising for a medicinal product be brought to an end.

The Danish Medicines Agency may furthermore order the party responsible for illegal advertising to publish a decision stating that the advertising must be stopped or to publish a corrective statement in relation to the advertisement. The form and content of such publications are decided by the Danish Medicines Agency.

3.8. Use of the word pharmacy

The word 'pharmacy' must generally not be used in advertising for non-pharmacy restricted medicinal products, cf. section 65 of the Danish Medicines Act.

This extends to certain over-the-counter medicinal products, herbal medicinal products, strong vitamins and mineral preparations as well as a number of veterinary medicines. If the party responsible for the advertisement can prove that the medicinal product is sold in more than half of Denmark's pharmacies, it is, however, permitted to use the word 'pharmacy'.

The requirement that the medicinal product must be available in the majority of pharmacies must be fulfilled always, and documentation to that effect must be made available to the Danish Medicines upon request. Pharmacies have a duty to sell all pharmacy-only medicinal products. For this reason, it is always allowed to use the word 'pharmacy' in advertising for pharmacy-only products.

4. Advertising to the public

4.1. Prescription-only medicinal products, etc.

Section 66(1) of the Danish Medicines Act prohibits advertising to the general public in respect of:

Prescription only medicinal products,

Medicinal products which are inappropriate for use unless the patient has first consulted a doctor to obtain a diagnosis or for monitoring of the treatment, i.e. medicinal products which cannot be used rationally or should not be used at all without the prior advice of a doctor.

Due to the provision of (i) and the prohibition against the mentioning of serious diseases laid down in section 10(1)(xiii), cf. 4.5.2 below, this provision has a very limited independent area.

Medicinal products covered by the Executive Order on Euphoriants.

Due to the provision of (i), this provision has a very limited independent area.

4.2. Professional journals

It is legal to advertise for prescription-only medicines in professional journals targeted at health professionals. This is because advertising in such media is not considered to be targeted at the general public, regardless of the fact that the journal, by its nature, may be read by others than health professionals to a certain extent. A journal is deemed to be a professional journal when its content is predominantly technical and the vast majority of the readers and subscribers are health professionals.

According to section 66(3) of the Danish Medicines Act, professional journals with an audience other than health professionals may be granted permission to print advertisements for prescription-only medicines. The concerned professional journal must submit a reasoned application to the Danish Medicines Agency. In deciding whether to grant permission, the Danish Medicines Agency attaches importance to whether the professional group concerned has a special and commendable interest in the use of and knowledge about prescription-only medicines. Depending on the circumstances, the permission may be limited to certain types of medicinal products.

4.3. Surreptitious advertising

Advertisements directed at the public should be presented in such a way that it is clear that it is an advertisement and that the product being advertised is a medicine, cf. section 4 of the Executive Order on Advertising. This is to ensure that the target group knows that the information conveyed is an advertising message and may assess the message in that view.

Any form of surreptitious advertising for a medicinal product is prohibited in other words, e.g. advertising camouflaged as editorial text in a journal, exposure of a medicinal product in a film (so-called product placement) or games on the internet with an underlying advertising message.

4.4. Compulsory information

According to section 5(1) of the Executive Order on Advertising, an advertisement for a medicinal product must contain the information listed in 1 through 8 below (compulsory information), cf. however, section 4.4.2-3 of these guidelines regarding special requirements to compulsory information in advertisements outdoor, in movies, on radio and TV, etc.:

The name of the medicinal product and its common name. The common name is determined unambiguously in connection with the approval of the medicinal product. The common name must appear as a clear indication of the active ingredient of the medicinal product. This requirement is not met if, for example, the common name is only mentioned in a warning about the use of the active ingredient concerned.

Dated price (registered price) including VAT as well as a reference to a current price on www.medicinpriser.dk if it is a pharmacy-only medicinal product, cf. section 60(1) of the Danish Medicines Act.

Effect, cf. however, section 10(1)(xiii) of the Executive Order on Advertising. The effect of the medicinal product must be specified in compliance with the summary of product characteristics. If the wording of the summary of product characteristics is considered to be difficult to understand for ordinary users of medicine, it may and should be rewritten in an easily understandable language targeted at ordinary users of medicine. Indications which the holder of the marketing authorisation deems irrelevant to the ordinary user of medicine (or certain groups of users which the advertisement is specifically aimed at) may be omitted. If the approved indications comprise serious diseases, there must be no mentioning of such diseases, cf. section 10(1)(xiii) of the Executive Order on Advertising. Read more under 4.5.2.

Adverse reactions. The adverse reactions that appear from the summary of product characteristics must generally be included in the compulsory information. However, some adverse reactions may deemed less relevant for reasons of rarity, nature or other objective criteria and may therefore be omitted. Only the holder of the marketing authorisation should assess what adverse reactions to omit, and not for example a chain of stores that prepare its own advertisements for medicinal products. If the Danish Medicines Agency makes inquiries as to why some adverse reactions of the summary of product characteristics have been left out, the holder of the marketing authorisation must be able to explain this. If a medicinal product has no adverse reactions, there must be no mentioning of adverse reactions; The text 'Adverse reactions: non' must thus not appear, cf. section 10(1)(ii), of the Executive Order on Advertising.

Dosage. The dosage must be specified in compliance with the summary of product characteristics. However, if some indications have been omitted, cf. the above, the corresponding dosage must not be included.

An express invitation to the user to read the information on the patient information leaflet contained in the pack or on the label of the pack.

Other information necessary for the correct and appropriate use of the medicinal product, e.g. precautions or drug interactions.

It is the holder of the marketing authorisation who must assess what information is relevant to include in order to give the user a correct and adequate picture of the medicinal product and its use, cf. section 63 of the Danish Medicines Act. Basically, any contraindications, special precautions, drug interaction, relevant overdose information, withdrawal periods and special warnings that are mentioned in the summary of product characteristics ought also to be included in advertising. Information which based on the objectivity criterion is considered irrelevant to bring to the public may be omitted. If the Danish Medicines Agency makes inquiries as to why one or several adverse reactions of the summary of product characteristics have been left out, the holder of the marketing authorisation must be able to explain this.

4.4.1. Outdoor advertising, advertising in movies and on the radio

Pursuant to section 6 of the Executive Order on Advertising, outdoor advertising, advertising in movies, including video, and on the radio must include the following information:

The name of the medicinal product and its common name. The common name may be omitted if the medicinal product has more than one active ingredient.

Effect.

Significant adverse reactions.

An express invitation to the user to read the information on the patient information leaflet contained in the pack or on the label of the pack.

An express recommendation to contact a doctor (or veterinarian) or a pharmacy in case of doubt.

4.4.2. Advertising on TV

Pursuant to section 7 of the Executive Order on Advertising, advertising on TV must include the following information:

Name of the medicinal product.

Effect.

Significant adverse reactions.

An express invitation to the user to read the information on the patient information leaflet contained in the pack or on the label of the pack.

An express invitation to read more about the medicinal product on the concerned TV channel's teletext pages and on the internet. The holder of a marketing authorisation has a duty to publish all information mentioned in section 5 of the Executive Order on Advertising on the teletext pages and on the internet.

The teletext page number and internet address where the information of (iv) has been published.

The information must either be easy to read on screen or most be read aloud. The teletext page number and internet address must, however, be displayed as text on the screen, cf. section 7(3) of the Executive Order on Advertising.

4.4.3. Advertising on monitors in sales outlets

The rules applicable to advertising on TV also apply to advertising on monitors (screens) placed in pharmacies or other shops selling medicinal products provided that the pharmacy or shop concerned offers free access to the internet from an on premises computer, information display panel or similar, cf. section 7(4) of the Executive Order On Advertising.

The advertisement must explicitly mention such free access to the internet in the pharmacy or shop and must refer to the internet address where further information can be found about the medicinal product.

All information must be displayed as text on the screen, cf. section 7(5) of the Executive Order on Advertising. Contrary to advertising on TV, it is not sufficient to read aloud the compulsory information.

The rules on advertising of homeopathic medicinal products on monitors (displays) in pharmacies or other shops selling homeopathic medicinal products are laid down in section 14(5) of the Executive Order on Advertising.

4.4.4. Veterinary medicinal products

If a veterinary medicinal product has been approved for use in several species, the compulsory information must generally contain information about the product's indication for each species.

If an advertisement is exclusively aimed at persons with a specific interest in one of the species, the compulsory information may pursuant to section 5(3) of the Executive Order on Advertising be limited to information relevant to the that particular species.

For example, the compulsory information of an advertisement for a medicinal product approved for use in calves, cows, pigs, poultry, dogs and cats printed in a journal for pig-farmers may be limited to information about the medicinal product's indication for use in pigs, and where printed in a brochure handed out at a pharmacy and exclusively addressing the treatment of dogs it may be restricted to information about the medicinal product's indication for use in dogs.

If using this methods to target the compulsory information to a specific species, any information that is irrelevant to the treatment of that particular species must be omitted.

A brochure that describes the effect of a medicinal product in general terms and which is distributed to a multitude of persons must include the compulsory information in full, i.e. information about the medicinal product's indications for use in all species.

4.4.5. Requirements to form, etc.

All compulsory information must appear (or be read aloud) so clearly that the obvious target group of the advertisement can read it (or hear it) easily to perceive it, cf. section 8 of the Executive Order on Advertising.

When the compulsory information is presented as text, which is most often the case, the letter height and thickness as well as the contrast between text and background must be adjusted to the circumstances under which the target group is to see the advertising, taking into account factors such as viewing distance and lighting conditions.

If an advertisement, e.g. a display window, consists of several elements forming a coherent whole, the compulsory information must not necessarily appear from each element. It is enough that the compulsory information appears from one single, separate element, forming part of the display on equal footing as the other elements.

4.5. Specific prohibitions

Section 10(1) of the Executive Order on Advertising lays down specific restrictions on the contents of advertising to the general public.

The advertisement must not

give the impression that it is unnecessary to consult a doctor or veterinarian,

give the impression that the effect of the medicinal product is guaranteed, that it has no side effects or is better than or equivalent to the effect of another treatment, including another medicinal product,

suggest that the health of the person can be enhanced by taking the medicinal product,

suggest that the health of the person can be deteriorated by not taking the medicinal product,

be exclusively or principally directed at children,

make recommendations by health professionals, scientists or persons, associations of persons, institutions, companies, etc. who, because of their prestige, etc. could encourage consumption of medicinal products, cf. 4.5.1 below,

compare the medicinal product with a foodstuff, cosmetic or other consumer product,

give the impression that the safety or efficacy of the medicinal product is due to the fact that its active ingredients are natural,

give information that could lead to erroneous self diagnosis,

contain exaggerated, alarming or misleading claims of recovery,

use, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof,

mention that the medicinal product has been granted a marketing authorisation by the authorities,

4.5.1. Recommendations by persons enjoying particular prestige

The prohibition against using persons, etc. who enjoy particular prestige, etc. laid down in section 10(1)(vi), extends to persons whose prestige stem from their educational background, work experience or similar, and persons whose prestige is founded in personal qualities.

First, the term "particular prestige, etc." covers the celebrity or respect earned by persons and associations of persons by virtue of their specialist knowledge or expertise, e.g. health professionals, scientists or professors.

Second, the term covers the term celebrity which has no particular ties to medicinal products, health, etc., or a particular status associated with a specific trade. This could be either public persons, e.g. actors, sports celebrities, and TV hosts, or anonymous persons having a particularly prestigious or authoritative job, e.g. police officers.

The prohibition does not only concern individuals but also associations of persons, institutions, companies and the like. Therefore, using a hospital or a football team in medicine advertising is just as prohibited as using a doctor or a famous football player.

The 'recommendation' embodied in the provision does not need to be express. The mere presence of persons, associations of persons, etc. who enjoy particular prestige in the form of a name or picture would in itself fall to be considered here.

The prohibition also covers the presence of a person in a white coat whom consumers would perceive to be a health professional, even though the person is actually an (unknown) actor. The person could, by virtue of his or her appearance as a health professional, encourage consumers to use a medicinal product.

4.5.2. Serious diseases

The assessment of whether or not a disease is serious, cf. section 10(1)(xiii), is based on a specific evaluation, determining, among other things, whether the disease generally necessitates a doctors appointment, requires treatment, causes severe pain, may lead to a permanent deterioration in health, confines the person to bed, incapacitates the person, may shorten the person's life or reduces the quality of life.

The assessment of what is considered a symptom of a serious disease is based on whether the actual mentioning of the symptom suggests a specific disease. It is not prohibited to mention a condition just because theoretically it may be a symptom of a serious disease.

4.6. Advertising to personnel in certain outlets

Advertising targeting owners or employees in outlets authorised to sell non-pharmacy restricted over-the-counter medicinal products or non-pharmacy restricted medicinal products for production animals is governed by the same provisions on compulsory information, reminders and information material as apply to health professionals when the advertising concerns such medicinal products. However, the provisions only apply to employees handling said medicinal products, cf. section 28 of the Executive Order on Advertising. Detailed information about these provisions is provided under 5.1-4 below.

Owners or employees in outlets authorised to sell non-pharmacy restricted over-the-counter medicinal products and non-pharmacy restricted medicinal products for production animals are also governed by the provisions of sections 21-27, section 29 and section 30 of the Executive Order on Advertising. However, the provisions only apply to employees handling the mentioned medicinal products, cf. section 28 of the Executive Order on Advertising. This group of persons should therefore be equated with health professionals in relation to the rules on financial benefits, etc. of Part VII of the Executive Order on Advertising. This implies, among other things, that in connection with the advertisement for or professional information about such medicinal products, hospitality may be provided or offered in the form of payment of direct expenses for meals, travel, accommodation, etc. to persons covered by section 28. Detailed information about the provisions governing financial benefits is provided under 5.5-5.7 and 6.

Owners of outlets authorised to sell non-pharmacy restricted medicinal products are moreover prohibited from giving or offering the general public hospitality in connection with advertising for or professional information about medicinal products, cf. section 20 of the Executive Order on Advertising.

4.7. Hospitality

In connection with the advertising for medicinal products and professional information about medicinal products, hospitality in the form of payment of expenses for meals, travelling, accommodation, etc. must not be offered or given, cf. section 20 of the Executive Order on Advertising. This is an absolute prohibition, regardless of extent and value of hospitality.

5. Advertising to health professionals

5.1. Compulsory information

According to section 11(1) of the Executive Order on Advertising, advertising targeting health professionals must include the information specified in (i) through (xi) below (compulsory information):

The name of the medicinal product and its common name. The common name must be indicated using the same font and same appearance as the invented name. Combination products without a common name must carry clear information about all common names for all active substances. 'Same font' means that the letters must have the same height, width, design and thickness. However, it is permitted to apply different spacing between the letters of the invented name and common name, e.g. so that the spacing between the letters of the common name is narrower than that of the invented name. The invented name and common name must be equally clear. This is generally achieved by writing the names in the same colour with the same background colour. In respect of a combination product for which a common name has not been assigned, the common names of the active substances must not necessarily be written in the font used for the invented name.

The name of the marketing authorisation holder.

Indications text as specified in the summary of product characteristics. Where an advertisement exclusively targets a limited group of health professionals, the indications text may be abbreviated to only include indications relevant for that particular group. Generally, the wording of the summary of product characteristics must be reproduced word for word in the compulsory information. If the indications text is so long that it is considered inappropriate to reproduce it in its entirety, the indication text may be rewritten and abbreviated, e.g. leaving out less relevant information. The indications text may under no circumstances be rewritten in a way that may lead to misinterpretations, including suggesting that indications are different or wider than what appears from the summary of product characteristics. If the wording of the summary of product characteristics is not reproduced word for word, this must clearly appear from the advertisement. Furthermore, it must be stated that the summary of product characteristics in its entirety can be obtained from the holder of the marketing authorisation. The following phrase can be used: "The indications text has been rewritten and/or abbreviated compared with the full summary of product characteristics approved by the Danish Medicines Agency. The summary of product characteristics can be ordered free of charge from xx (the holder of the marketing authorisation)". This information must be written in a font size that is either larger or distinguishes itself clearly from the actual compulsory information. If this information is missing, the advertisement is inadequate and consequently non-compliant with section 63 of the Danish Medicines Act.

Contraindications. Generally, any contraindications contained in the summary of product characteristics must be included in the compulsory information. If the information about contraindications in the summary of product characteristics is so long that it is considered inappropriate to reproduce it word for word, it may be rewritten and abbreviated, e.g. leaving out less relevant information. The exact delimitation of what contraindications to include rests on an estimate. Such estimate must be based on objective criteria with due regard to the requirements of section 63 of the Danish Medicines Act. If contraindications appearing from the summary of product characteristics are omitted, this must clearly appear from the advertisement. Furthermore, it must be clearly stated that the summary of product characteristics in its entirety can be obtained from the holder of the marketing authorisation. Reference is made to the proposed phrase listed under 'Indications' above.

Adverse reactions and risks. Generally, any adverse reactions and risks, i.e. interactions, warnings, overdose risks, withdrawal, etc. contained in the summary of product characteristics must be included in the compulsory information. If the wording of the summary of product characteristics, for reasons of terminology or extent, cannot be reproduced word for word, the information may be rewritten and abbreviated, e.g. leaving out information considered less relevant in the specific case. If the wording of the summary of product characteristics is not used, this must appear clearly from the advertisement. Furthermore, it must be clearly stated that the summary of product characteristics in its entirety can be obtained from the holder of the marketing authorisation. Reference is made to the proposed phrase listed under 'Indications' above.

Dosage. The dosage must be specified in compliance with the summary of product characteristics. If the wording of the summary of product characteristics, for reasons of terminology or extent, cannot be reproduced word for word, the information may be rewritten and abbreviated, e.g. leaving out information considered less relevant in the specific case. If the wording of the summary of product characteristics is not used this must appear clearly from the advertisement. Furthermore, it must be clearly stated that the summary of product characteristics in its entirety can be obtained from the holder of the marketing authorisation. Reference is made to the proposed phrase listed under 'Indications' above. The rewriting of dosage information should be done carefully as any changed wording must not lead to misunderstandings.

Pharmaceutical forms. Generally, all pharmaceutical forms available must be specified. If a medicinal product has been approved in several pharmaceutical forms with different indications, and the advertisement only addresses one of the pharmaceutical forms, the advertisement should contain information about that pharmaceutical form only. Furthermore, it must appear from the advertisement that the medicinal product is also available in other pharmaceutical forms, cf. section 11(2) of the Executive Order on Advertising. In respect of medicinal products intended for several species, please refer to 5.2 below.

Pack sizes. All pack sizes of the medicinal products must be specified. In special cases where only a section of the indications text is included in the advertisement, cf. the above, pack sizes that cannot be used for the concerned indication should be omitted. See also 5.2 below about medicinal products for several species.

Dated price (registered price) including VAT as well as a reference to a current price on www.medicinpriser.dk if it is a pharmacy-only medicinal product, cf. section 11a(4) of the Executive Order on Advertising. The advertisement must at least contain information about the price in connection with the sale to individuals, cf. section 2 of the executive order on the calculation of consumer prices of pharmacy-only medicinal products and various OTC products. To the extent of relevance to the target group of the advertisement, the advertisement must furthermore contain the price applicable to deliveries to institutions and persons referred to in section 2(3)-(6) of the executive order on the calculation of consumer prices of pharmacy-only medicinal products and various OTC products. The price quoted must to the extent possible be current, i.e. ruling at the time when the advertisement reaches the recipient, cf. section 63 of the Danish Medicines Act. The price may be omitted in advertisements that are sent out over a long period of time if a price list or similar is included instead and in advertisements the target group of which is limited to students only, cf. section 11(4) of the Executive Order on Advertising. If the requirement to quote a price is fulfilled through the enclosing of a currently updated price list, etc., the provisions about price quoting will only be considered to have been fulfilled if the advertisement contains current prices or is enclosed with current prices. In some journals, advertisements must be handed in a relatively long time before the actual date of release. Consequently, it may not be possible to fulfil the requirement of quoting absolute current prices. In such cases, minor deviations from the price ruling on the date of release are accepted. The size of deviation allowed depends on the specific case. Deviations that may influence the users choice of medicinal product are not acceptable. If an advertisement includes a price comparison, the requirement of quoting current prices is generally considered to be unconditional.

Dispensing group.

Reimbursement status. The advertisement must contain information about whether the medicinal product is eligible for general reimbursement. By contrast, the advertisement is not required to contain information about the possibilities of granting the patient special individual reimbursement. If, in exceptional cases, there is reason to include information about individual reimbursement, e.g. single reimbursement, it must explicitly appear from the advertisement that the reimbursement available is based on the individual case and granted upon application only. All compulsory information must appear so clearly that the obvious target group of the advertising can read it easily, cf. section 11(5) of the Executive Order on Advertising.

5.2. Veterinary medicinal products

When a veterinary medicinal product has been approved for use in several species, the compulsory information must generally contain information about the product's use in each species. If the advertisement exclusively addresses treatment of one single species, the compulsory information may be limited to information relevant to that particular species, cf. section 11(3) of the Executive Order on Advertising.

In this case, the compulsory information must generally be adjusted to fit the species in question, i.e. leaving out information about irrelevant pharmaceutical forms or pack sizes, etc.

Where the compulsory information has been reduced to addressing the treatment of only one species, it must clearly appear that the medicinal product has also been approved for treatment in other species. Furthermore, it must be stated that information about all species can be found in the summary of product characteristics, which can be obtained from the holder of the marketing authorisation. Otherwise, the advertisement is inadequate, cf. section 63 of the Danish Medicines Act.

5.3. Reminders

Advertisements exclusively addressing health professionals may be limited to the name of the medicinal product and the common name, cf. section 12 of the Executive Order on Advertising. This also applies if a pharmaceutical company sends out a product list with the names of all medicinal products (without any comparisons whatsoever) within a given therapeutic area. If other information is included, e.g. prices, the advertisement falls outside the scope of the provision, and all compulsory information must be included. However, a company name and logo identifying the sender of the advertisement may be indicated.

5.4. Information material

According to section 13 of the Executive Order on Advertising, any information material about a medicinal product that is sent or handed over to health professionals with the purpose of promoting sales must as a minimum contain the information specified in section 11(1) of the Executive Order on Advertising (the compulsory information, cf. above) and the date when the material was last prepared or last updated.

All information of the material must be exact, current, verifiable and adequately detailed, enabling the recipient to form his own personal opinion about the therapeutic value of the medicinal product, cf. section 13(2) of the Executive Order on Advertising. Any quotations, tables and illustrations taken from medical journals, scientific works, etc. used in the material must be reproduced loyally and the exact source must be referenced, cf. section 13(3).

The summary of product characteristics is considered as the basic documentation for the qualities of a medicinal product. In addition, clinical trials that have been published in recognised and independent works, professional journals, etc. may be used, cf. section 13(4) of the Executive Order on Advertising. 'Independent' means that the entity publishing the work or journal has no interest in the sale or other form of promotion of medicinal products. Such studies must have been subject to an independent assessment in advance.

The so-called 'abstracts' and 'data on file' 2 cannot be used as documentation since they do not meet the above-mentioned requirement. 'Data on file' having undergone an independent assessment that ranks on a par with the assessment that is made prior to the inclusion in recognised scientific journals and having been recognised as reliable by the independent assessment may, however, be used as documentation until corresponding information has been published, publication of the information has been rejected or new information has overwritten the scientific validity of the material.

2 'Data on file' means a final and signed study report setting out the results of the study produced through statistical processing of data in compliance with the protocol. Detailed results, including individual data, must appear from one or more appendices. A synopsis of the report must concisely, yet exhaustively, describe the design, treatment, patient material and most important results. The reference to the report must include the full report title and study code, the name of the principal investigator and medically responsible person as well as year and company name.

It is also possible to refer to information at www.medicin.dk and the Institute for Rational Pharmacotherapy all of which rests on an scientific and independent assessment.

The fact that the documentation material form part of the application procedure for the approval of a medicinal product does not in itself imply that it is adequate to be used as documentation for the medicinal product.

5.5. Financial benefits for health professionals

According to section 21(1) of the Executive Order on Advertising, financial benefits may generally not be offered or given to health professionals as part of advertising or otherwise with the intention of promoting the sale of a medicinal product.

The prohibition does not extend to presents of an insignificant value when such presents are relevant to the practice of the recipient or if they are given in connection with a noteworthy day, e.g. the recipient's promotion or a milestone birthday, cf. section 21(2) of the Executive Order on Advertising.

As a result hereof, pharmaceutical companies may legally offer presents in kind of insignificant value when the presents are related to the activities of the business of the health professional in question.

The Executive Order on Advertising does not set an upper limit on the value of such presents, however, if the total value from the giver to the individual health professional does not exceed DKK 300 in a calendar year, the offering of such present(s) is legal.

The value is not based on what the giver may have paid for the present – perhaps as result of excessive discounts - but on what the recipient would have paid if he was to buy a corresponding article under normal terms. In other words, it is the market value that decides the value of the present.

Examples of presents that 'are relevant to the practice of the recipient' could be thermometers, ball pens, mouse pads, calendars or desk pads, whereas e.g. art, architect-designed lamps or radios – even though they may very well be placed in the practice of the health professional – do no fall under the exclusion of section 21(2).

Examples of 'noteworthy days' other than those specified in section 21(2) could be anniversaries, job switches, resignations, etc.

A present that is significantly financed by a pharmaceutical company is generally covered by section 21 of the Executive Order on Advertising even though the giver is apparently a third party when it should be clear to the recipient that the involvement of the pharmaceutical company is a decisive and necessary precondition for the offering of the present.

Section 21 of the Executive Order on Advertising also covers 'image presents' from pharmaceutical companies to health professionals. Thus, it makes no difference in this regard whether or not the present is directly related to the promotion of a certain medicinal product since the company's interest in offering such financial benefits must be assumed to be justified in a wish to market the company and its products. Consequently, image presents must be regarded as being given as promotional presents.

The rules defining what presents and other financial benefits may be offered to health professionals are matched by a prohibition that health professionals may not request or receive offers in violation of section 21(1), section 22 and section 23 of the Executive Order on Advertising.

5.5.1. Competitions

The prohibition of section 22 of the Executive Order on Advertising stipulating that competitions must not be arranged for health professionals and that prizes must not be offered to them is absolute. The nature of the competition and value of the prize are unimportant. Whether or not a competition is held by a pharmaceutical company in direct relation to the promotion of a certain medicinal product has no bearing this assessment. A competition held for health professionals as part of a company's activities to promote its image must be assumed to be justified in a wish to market the company and its products. This being the case, such competition must be assumed to have been arranged as part of advertising in violation of the provision.

5.5.2. Remuneration for professional services

The prohibition against offering financial benefits to health professionals does not extend to the remuneration to health professionals or pharmacies for services when such remuneration is proportionate with the services offered. Both the offerer and recipient of remuneration shall, upon request, present information about the calculation basis for setting such remuneration to the Danish Medicines Agency, cf. section 23(1) of the Executive Order on Advertising.

Remuneration may only be in the form of a cash payment. It must not take place through off-setting, transferring of benefits in kind or other indirect method, cf. section 23(2) of the Executive Order on Advertising.

Consequently, a health professional may receive payment for a service offered to a pharmaceutical company if the service is a natural element in an ordinary, mutually-binding agreement between the health professional and the company and if the services offered and consideration received in return are proportionate.

Examples could be fees for rental of display space at a pharmacy for the advertisement of a medicinal product, advertisement in a pharmacy journal, etc. Similarly, it is possible to remunerate doctors when they offer professional aid in connection with clinical trials or the preparation of information material about medicinal products. However, when it comes to the payment of professional services offered by doctors, it should be emphasised that a doctor's affiliation to a pharmaceutical company is subject to the prior approval from the Danish Medicines Agency, cf. section 3(2) of the Danish Pharmacy Act.

5.6. Hospitality and sponsorship, etc.

The prohibition referred to under item 5.5 on the offering of financial benefits to health professional is mitigated by a number of explicit exclusions in respect of sponsorship and hospitality, etc.

Section 25(1) of the Executive Order on Advertising allows the giving or offering of the below listed financial benefits to health professionals:

Hospitality in the form of payment of direct expenses for meals, travel, accommodation, etc. in connection with the advertising for or professional information about medicinal products, and

Professional information about and training related to medicinal products in the form of payment of direct expenses in connection with courses, congresses and other professional activities in which the health professional participates or arranges.

The provision of section 25(1)(i), gives health professionals the opportunity of sponsorship of direct expenses for meals, travel, accommodation, etc. in connection with the advertising for or professional information about medicinal products. This also applies to hospitality in connection with the participation in courses, and other pharmaceutical or pharmacy-related activities.

The provision of section 25(1)(ii), gives health professionals the opportunity of sponsorship of direct expenses for internal courses and other professional activities. This could for example be a fee paid to an external speaker or expenses for the purchase of course material.

5.6.1. Level and extent

The services mentioned in section 25(1)(i), must be kept at a reasonable level and must be closely linked to the main purpose of the meeting, including must be subordinate in time relative to the promotional or professional activity in question, cf. section 25(2) of the Executive Order on Advertising. This implies, for example, that a full day seminar from 9:00 to 17:00 may include breakfast on arrival, lunch and a light dinner to mark the end of the seminar. Such hospitality must not cover anyone else than health professionals, cf. section 25(2) of the Executive Order on Advertising. The spouse of a health professional may participate on a trip in connection with an event held by a pharmaceutical company provided that the spouse pays for his or her own related expenses.

5.6.2. Events held abroad

If promotional or professional activities are held abroad, payment of the benefits mentioned in section 25(1) may only take place if the holding of the event abroad is justified by material content-related, practical or financial circumstances, cf. section 25(3) of the Executive Order on Advertising.

For example, this could be the case if it is significantly cheaper to send a group of health professionals to an event abroad than it would be to organise a similar event at home.

Documentation of such material circumstances justifying the holding of the event abroad must upon request be presented to the Danish Medicines Agency, cf. section 25(3) of the Executive Order on Advertising.

5.6.3. Public meetings

Pharmaceutical companies are allowed to sponsor public meetings that provide professional information about medicinal products hosted by pharmacies, cf. section 26(1) of the Executive Order on Advertising.

The amount paid to sponsor a pharmacy's professional information meetings about medicinal products for the public must not exceed the direct expenses related to the hosting of the activity in question, cf. section 26(2) of the Executive Order on Advertising.

For example, if a pharmacist decides to hold a professional meeting at his own premises, he may not receive a sponsorship fee neither for himself nor for the payment of expenses for renting the premises. However, the fee payable to an external speaker and costs related to cleaning the premises may be legally sponsored.

Representatives from the sponsor may not participate actively at the event, cf. section 26(2) of the Executive Order on Advertising. For example, if a pharmacist hosts an information meeting about the treatment of obesity with medicinal products, and a company that sells weight loss products is sponsoring the event, a representative from that company is not allowed to discuss the company's products or obesity treatment or to participate in the holding of the event in any other way.

Similarly, pharmaceutical companies may sponsor public meetings that provide professional information about medicinal products hosted by owners of outlets that sell non-pharmacy restricted over-the-counter medicinal products and non-pharmacy restricted medicinal products for production animals when such meetings concern these medicinal products in question, cf. section 28 of the Executive Order on Advertising.

The prohibition against offering hospitality to the public in connection with advertising for and professional information about medicinal products, cf. section 20 of the Executive Order on Advertising means that free accommodation may not be offered in connection with public meetings. Accommodation may only be offered against payment.

5.7. Entertainment

Pharmaceutical companies may not as part of advertising activities pay expenses for health professionals' participation in purely social or cultural events, cf. section 27 of the Executive Order on Advertising. This prohibition is broad and extends to cover e.g. the payment of tickets to go to the theatre, a museum or football match. The prohibition applies regardless of the size of payment.

However, the provision does not apply to the payment of entrance fees when the professional event takes place in a conference room, etc. at museums or other cultural places. In these cases, payment of the entrance fee serves the purpose of letting health professionals participate in professional events. Thus, it does not constitute payment for participation in purely social events.

6. Cost-reasoned discounts – delimitation and definition

According to section 21(1) of the Executive Order on Advertising, financial benefits may not be offered or given to health professionals as part of advertising or otherwise with the intention of promoting the sale of a medicinal product. A discount will always be of financial benefit to the recipient, which is why discounts may generally not be offered to health professionals.

However, the prohibition does not apply to discounts on a medicinal product if such discount reflect cost-savings for the supplier and is a direct consequence of a purchase behaviour exhibited by the recipient. Such discounts are called "cost-reasoned discounts", cf. section 29 of the Executive Order on Advertising.

The access to granting cost-reasoned discounts covers all medicinal products and concerns all links in the medicinal product supply chain, including pharmacies.

The rules governing the access to granting cost-reasoned discounts only apply to the relationship between supplier and retail distributor, regardless of whether the supplier is a manufacturer, importer or wholesaler. Any discounts between other companies in the supply chain, e.g. between manufacturer/importer and wholesaler is outside the scope of the rules regulating cost-reasoned discounts. Manufacturers and importers of medicinal products delivering products to the retail distributors themselves are covered by all the rules regulating cost-reasoned discounts in respect of these activities.

Cost-reasoned discounts must be stated based on the supplier's direct and indirect costs related to the delivery of the medicinal products to pharmacies or other retail distributors, e.g. costs related to administration, wages, storage, delivery vans, etc.

Cost-reasoned discounts may e.g. be granted as part of an agreement on fewer deliveries and larger volumes/orders per delivery. In this way, the supplier saves costs, partly as a result of fewer costs related to the delivery itself, partly as a result of proportionately fewer administration costs related to the handling of the deliveries. For example, if a retail distributor agrees to change his five weekly deliveries to one delivery per week instead, there is a basis to offer a discount – provided that the supplier's standard terms are in fact five weekly deliveries.

Furthermore, the retail distributor may demonstrate flexibility as regards the time of delivery. Consequently, a pharmacist who has his own store of medicinal products, may accept a certain extent of irregularity in relation to the delivery times of the supplier. It is thus possible for the supplier to arrange a delivery that is expedient and costs-saving for him.

The purchase behaviour – which forms the basis for granting discounts – may be exhibited by one retail distributor alone or a group of retail distributors. This means that a supplier's cost-saving that is e.g. based on a number of pharmacists' collective purchase behaviour may form the basis for offering discounts.

Discounts that are exclusively based on a change in circumstances at the discount provider (e.g. a wholesale distributor) are not allowed. As mentioned before, cost-reasoned discounts assume that the retail distributor exhibits a certain rational purchase behaviour, and they cannot be based on other general rationalisation measures enacted by the discount provider – an example could be the introduction of new cost-cutting technology in the wholesaler supply chain.

The executive order does not stipulate that suppliers are obliged to offer discounts. However, suppliers are obliged to follow the same principles for calculating discounts to recipients that exhibit the same purchase behaviour, cf. section 29(2) of the Executive Order on Advertising. It follows that suppliers who calculate discounts to recipients that exhibit the same purchase behaviour must apply the same principles for stating the cost-saving circumstances that form the basis for offering discounts. In other words, recipients exhibiting the same purchase behaviour have equal possibilities of earning the same discount on medicinal products associated with the same handling costs.

A discount offered under the given delivery terms in connection with the purchase of a specific product number must be assumed to be available on the same terms as apply to other product numbers delivered on the same terms. Consequently, the size of discount offered from product number to product number cannot vary when the medicinal products in question are supplied in the same delivery with the same handling costs.

A specific agreement between wholesale distributor and manufacturer on cost-saving exploitation of storage facilities at the wholesale distributor does not allow the wholesale distributor to offer a special discount to pharmacies on products from that manufacturer in question. However, varying discounts may be offered on different products to which different delivery requirements apply, e.g. requirements to specific storage conditions. If a supplier offers varying discounts on different medicinal products in the same delivery, the supplier must be able to justify this in special differences between the medicinal products.

Any discounts, price reductions, etc. offered in one link of the supply chain cannot be considered cost-savings in relation to specific deliveries in subsequent links in the supply chain. Any savings that the suppliers have made from purchasing medicinal products from the manufacturers cannot be passed on as discounts to the retail distributors. Thus, it is prohibited to offer discounts that depend on the suppliers' purchase prices and profit margins, which may vary between manufactures and products.

Discounts must be proportionate with the cost-saving earned, cf. section 29(2) of the Executive Order on Advertising. Consequently, discounts must not exceed the cost savings earned by the supplier in connection with the supply of medicinal products. However, the executive order does not specify an obligation to pass on the full cost-savings earned as discount.

The discount may only be offered to the direct buyer of the medicinal product, cf. section 30 second sentence, i.e. the pharmacies and other retail distributors who have exhibited a rational purchase behaviour thus offering a cost reduction to the supplier. The discounts may not be passed on to others.

Voluntary associations of pharmacies - pharmacy chains - may negotiate agreements on cost-reasoned discounts on behalf of the pharmacies. However, discounts achieved shall be rewarded to the pharmacies immediately and may not be accumulated in the chains, cf. section 36 of the Executive Order on Advertising. Thus, pharmacy chains may not keep a share of the discounts, and the discounts may not remain with the chains longer than necessitated by normal administrative routines, e.g. in connection with bank transfers and the issuing of invoices and credit notes.

The discount must reflect a reduction in the price of the products that are part of the delivery having triggered a discount, cf. section 30 of the Executive Order on Advertising. It is a case of non-compliance with the rules if suppliers offer discounts in the form of other financial benefits than a reduction in the price of the products in question. Any cost-reasoned discounts must appear clearly from the invoice or credit note issued immediately after the delivery of the products. The invoice or credit note must state the basis on which it is granted, and must be separated from other discounts, e.g. discounts granted on products that are available also in general sales outlets.

6.1. Special rules on the duty to display information, documentation, management statement and review of discounts granted on pharmacy-only medicinal products

Special supplementary rules govern the granting of cost-reasoned discounts on pharmacy-only medicinal products.

The duty to display information is intended to ensure openness and transparency of the suppliers' offering of cost-reasoned discounts on pharmacy-only medicinal products so that the offering of discounts refers to an informed basis. The duty to display information implies that pharmacies are informed of the discounts that are generally available on the market. Against this basis, the pharmacies have the possibility of assessing whether the accessible discounts have been obtained and whether any discount granted is in excess of what is cost-reasoned.

Openness and transparency of discount programmes are countered by the regard for competition interests in the industry. The duty to display information implies that the suppliers are required to disclose one of their competitive parameters, which may seem to inhibit competition. In laying down the rules on the duty to display information, it has therefore been important to maintain a balance between the need for openness in discount programmes and the preservation of competition in the industry.

The provisions of section 31 of the Executive Order on Advertising regarding the duty to display information about cost-reasoned discounts lay down the framework for the suppliers' publication of information. There are no detailed rules that exhaustively specify the scope of the suppliers' publication of information. It is up to the individual supplier of medicinal products to define the scope of their publication of information. The reason is that it is generally the suppliers who are familiar with the terms and costs associated with the supply of medicinal products.

The framework implies that the suppliers must publish the standard terms of delivery on which their general prices are based and where they do not offer discount. In this connection, the supplier is required to disclose the general circumstances related to the delivery of pharmacy-only medicinal products, e.g. information about the frequency of delivery, the volume/quantity that is to associated with the delivery and whether delivery can only be made at certain times.

In addition to this, the supplier must also publish any deviations from the standard terms that trigger discounts. Such deviations could be in the form of less frequent deliveries, increased delivery volumes/quantities or flexible times of delivery.

Any stated deviations must include the size of discount granted for each deviation. The supplier must publish the maximum level of discount for each type of deviation, just as it is possible to publish the discount level related to a combination of several types of deviation from the standards terms. The discount granted for the different types of deviations must be stated in a fixed amount, percentage rate or within an interval. The interval for the discount specified does not imply that the suppliers have an obligation to offer a discount within the interval to the pharmacies.

The information must be published clearly and be easily accessible on the website of the supplier, cf. section 31(1) of the Executive Order on Advertising.

Attention is called to the fact that pharmacies must not request or receive discounts other than those the supplier may legally grant, cf. section 71b(4) of the Danish Medicines Act.

Special requirements apply to the preparation and storing of documentation for cost-reasoned discounts offered or received as well as the supplier's cost-savings related to the supply of pharmacy-only medicinal products to pharmacies. Both discount providers and pharmacists are required to keep documentary evidence of any discounts offered or received for a period of three years, cf. sections 32 and 33 of the Executive Order on Advertising. Documentation in the form of invoices, credit notes and other appendix material must upon request be presented to the Danish Medicines Agency which may also order a discount provider to document that discounts have been granted in compliance with the rules, cf. section 71b(5) and (6). Credit notes related to cost-reasoned discounts may not be issued later than 30 days after the delivery has taken place. It must be clearly specified what deliveries the credit note is related to. The suppliers of medicinal products must ensure that the documentation under section 32 of the Executive Order on Advertising is stored in a manner that provides a clear connection between the information about the access to discounts (the duty to display information) and the invoice/credit note for each delivery made to a pharmacy, including information about how the discount is composed and calculated.

In addition, suppliers of medicinal products must prepare special management statements in respect of the offering of cost-reasoned discounts on pharmacy-only medicinal products. The management statement must specify that the discount has been offered in compliance with the information about the access to obtaining cost-reasoned discounts as prepared and published by the supplier, cf. the duty to display information, and that the discounts have otherwise been granted in compliance with the provisions of the executive order, cf. section 34 of the Executive Order on Advertising. Corresponding rules on management statements concerning discounts received apply to pharmacists and pharmacy chains, cf. the executive order on pharmacists' and pharmacy chains' presentation of financial statements.

The supplier's offering of cost-reasoned discounts on pharmacy-only medicinal products must be subject to an audit conducted by a state-authorised accountant or registered public accountant, cf. section 35 of the Executive Order on Advertising. The audit must include a test to see whether the stored documentation concerning cost-reasoned discounts complies with the provisions of the executive order. The audit moreover covers a test to see whether the discounts have been offered in compliance with the information about the access to obtaining cost-reasoned discounts as prepared and published by the supplier, cf. the duty to display information, and that the discounts have otherwise been granted in compliance with the provisions of the executive order. The detailed content of the audit will appear from the audit instructions prepared by the Danish Ministry for the Interior and Health in cooperation with the Institute of State Authorized Public Accountants in Denmark and the Danish Association of Registered Public Accounts. Corresponding rules on the audit of discounts received apply to pharmacists and pharmacy chains, cf. the executive order on pharmacists' and pharmacy chains' presentation of financial statements.

6.2. Bonuses, etc. to users of medicinal products

Bonuses or other economic advantage may not be paid or offered to users of medicinal products in connection with the sale of a pharmacy-only medicinal product, cf. section 71a(i), of the Danish Medicines Act. The users could be individual medicine users or groups of medicine users, e.g. an association of patients.

However, there is a special exclusion permitting the payment of bonus to hospital owners in connection with the sale of medicinal products to a hospital, cf. section 71a(ii), of the Danish Medicines Act.

7. Homeopathic medicinal products

The Executive Order on Advertising includes special rules on homeopathic medicinal products registered according to a special simplified procedure. The simplified procedure is characterised in that there is no documentation on the therapeutic effect of the medicinal product.

Also, the medicinal products have no summaries of product characteristics. Consequently, the general rules on advertising that are based on the summary of product of characteristics of the individual medicinal product cannot be used as simple as that.

Section 14 of the Executive Order on Advertising specifies the information that must be present in advertisements for homeopathic medicinal products for human and veterinary use, respectively. The advertisements may not include other information. However, they may contain general promotional statements, pictures, etc.

The following provisions of the Executive Order on Advertising apply to homeopathic medicinal products in parallel to other medicinal products: section 4 relating to surreptitious advertising, section 10 specifying a number of specific restrictions on how advertisement targeted at the general public must be presented and sections 20 through 30 governing financial benefits, hospitality and sponsorship, etc. and discounts.

7.2. Other homeopathic medicinal products

If a homeopathic medicinal product was to be approved according to the general rules of the Danish Medicines Act, i.e. via a marketing authorisation issued by either the Danish Medicines Agency or the Commission, the general rules on advertising would apply to this medicinal product.

8. The internet

8.1. Advertising on the internet

Medicinal product advertising on the internet must meet the same requirements as advertisements in other media. However, the rules must as required be read and interpreted with due consideration to the special characteristics of the internet, cf. section 9(1) of the Executive Order on Advertising.

The rules apply in parallel to banner advertisements, etc. clearly taking the form of advertising and information about medicinal products that pharmaceutical companies post on their websites when such information must be assumed to fall under the definition of advertising, cf. section 2 above 'Definition of advertising and scope of rules'.

The advertising rules distinguish between advertising for the public and advertising for health professionals. Advertising on the internet, which is accessible to all must comply with the requirements to advertising to the public.

8.1.1. Advertising to health professionals

The rules governing advertising to health professionals apply to internet pages that are only available to health professionals and persons engaged in the sale of medicinal products outside pharmacies, cf. section 9(3) of the Executive Order on Advertising.

The access to such pages must be securely restricted to certain groups of persons through access restriction via a personal access code, cf. section 9(3) of the Executive Order on Advertising. It is not enough if the user merely has to enter a password, which may even be the same used by all users. The minimum requirement is user identification by means of a unique user name or authorisation ID, etc. in combination with an associated personal password. This may be secured using the relevant website's own system or a general system, e.g. the user's digital signature.

8.2. Compulsory information

Advertisements for medicinal products must contain a number of compulsory information, cf. sections 5 and 11 of the Executive Order on Advertising. On the internet, which allows the linking of several pages, this requirement of posting compulsory information may be fulfilled by linking the advertisement to a separate page containing the compulsory information. The advertisement itself must clearly indicate that the link offers access to further information.

Representatives must be given adequate training and have sufficient scientific professional knowledge to enable them to give precise and complete information about the medicinal products they are promoting, cf. section 18(1) of the Executive Order on Advertising.

Such training may either be completed at the company of employment or another company or obtained through special programmes, e.g. the medical sales representative programme offered by the Danish Association of the Pharmaceutical Industry. It is the responsibility of the company that the representatives it engages have been given the adequate training ensuring that they possess the required scientific knowledge about the company's products.

The activities of the medical sales representatives are basically covered by the general rules on medicinal product advertising, including the requirement stipulating that advertising must provide adequate and objective information and must not be misleading.

9.2. Availability of summary of product characteristics, etc.

According to section 18(2) of the Executive Order on Advertising the medical sales representative must make available to all persons that they visit a summary of product characteristics including information about price and reimbursement rules for each product they promote.

The summary of product characteristics must be made available using the content (including wording and set-up) approved by the Danish Medicines Agency, however, may be incorporated into a more comprehensive product material as long as the summary of product characteristics can be separated from the other information.

9.3. Reporting of adverse reactions

If a representative receives information, including adverse reactions, about the use of one of the medicinal product he promotes from the persons he visits, the representative must report this to the holder of the marketing authorisation, cf. section 19 of the Executive Order on Advertising.

There are no specific rules on how the companies should treat reports on adverse reactions from medical sales representatives. However, section 53 of the Danish Medicines act imposes an obligation on the holder of a marketing authorisation to keep records of suspected averse reactions. Reports received from medical sales representatives should, where appropriate, form part of these records.

10. Distribution of samples of medicinal products

10.1. Distribution to the public

Distribution of samples free of charge to the public is prohibited. However, the Danish Medicines Agency may authorise free distribution, if such distribution is not for promotional ends, cf. section 67(1) of the Danish Medicines Act. However, the notes to the Danish Medicines Act provide that the Danish Medicines Agency is assumed to exert particular caution when it permits free distribution of samples of medicinal products to the general public. Generally, it is a condition that the recipients are limited and clearly defined, just as the distribution should have a commendable, non-promotional aim. The provision makes it possible to allow distribution of free medicinal products, e.g. in connection with informational activities.

10.2. Distribution to health professionals

The Danish Ministry for the Interior and Health specifies rules on the extent to which medicinal products can be distributed to health professionals, cf. section 67(2) of the Danish Medicines Act. Section 1 of the executive order on distribution of samples of medicinal products provides that free samples of medicinal products may only be distributed on the following conditions:

Samples of medicinal products may only be distributed to doctors, dentist, veterinarians and only to the extent that the concerned persons are qualified to prescribe the medicinal product, and are permitted to use the product as part of their activities within the medical, dental or veterinary field, respectively.

One sample only of each medicinal product may be distributed to every doctor, dentist or veterinarian every year. If the medicinal product is available in several pharmaceutical forms and strengths, a sample for each form and strength may be distributed.

The sample of medicinal product may not be larger than the smallest pack available on the market.

The pack must be marked "Free medical sample – not for resale".

Medical samples must be distributed only in response to a written request, signed and dated by the recipient.

Medical samples may only be supplied by the holder of the marketing authorisation or his representative. Samples may not be distributed from a pharmacy.

Each medical sample must be accompanied by its related summary of product characteristics.

Samples of medicinal products covered by the Danish Act on Euphoriants may not be distributed.

The holder of a marketing authorisation or his representative must keep a record of the number of medical samples supplied for each medicinal product, stating the pharmaceutical form and strength. Such record, including the requests received from the recipients must be stored for at least two years during which period it must be available to the Danish Medicines Agency, cf. section 2 of the executive order on distribution of samples of medicinal products.

Medical samples must only be used by doctors, dentists or veterinarian in their practice, cf. section 4 of the executive order on distribution of samples of medicinal products.

The distribution of a medical sample is always subject to a written request from the concerned doctor. The request must be dated and signed by the doctor. The signature of the doctor's secretary is not sufficient.

11. Questions, complaints and legal recourse

11.1. Questions and complaints

Questions about the rules governing medicinal product advertising and complaints about illegal advertising can be sent to the Danish Medicines Agency, Axel Heides Gade 1, DK-2300, or to the email address dkma@dkma.dk, cf., however, 11.2 below.

Generally, a person submitting a complaint about an advertisement cannot expect his identity to remain anonymous the reason being that the complaint is governed by the rules on access to public records laid down in the Danish Act on Access to Public Records and the Danish Public Administration Act.

Decisions made by the Danish Medicines Agency concerning cases about advertising for medicinal products may be referred to the Danish Ministry for the Interior and Health, Slotsholmsgade 10-12, DK-1264 Copenhagen K.

11.2. TV advertising

Complaints about medicinal product advertisements in TV and Radio must be sent to the Danish Radio and Television Board, Media Secretariat, Vognmagergade 10, 1., DK-1120 Copenhagen K, or to the email address rtv@mediesekretariat.dk.

The Radio and Television Board obtains a statement from the Danish Medicines Agency before making a decision on cases related to medicinal product advertising.

12. Self-regulatory bodies

12.1. Relationship between the Danish Medicines Agency and self-regulatory bodies

The supervisory activities of the Danish Medicines Agency in the advertising area is supplemented by self-regulatory bodies in the industry, which monitor the lawfulness of the companies' advertising activities in parallel with the Danish Medicines Agency. There are five self-regulatory bodies: The Danish Board of Drug Advertising (Nævnet for Medicinsk Informationsmateriale), the marketing board of VIF1 (VIF's Markedsføringsnævn), the Danish Board of Pharmacy Ethics (Apotekernes Etiske Nævn), the Danish Medical Association Ethical Council (Lægeetisk Nævn) and the Ethical Board of the Danish Association of Suppliers to the Health Industry (Helsebranchens Leverandørforenings Etiske Nævn).

Regardless of whether an advertisement falls under one of the activities of the self-regulatory bodies, a complaint can always be brought before the Danish Medicines Agency instead. When the Danish Medicines Agency assesses the complaint it may obtain a statement from the relevant self-regulatory body.

A decision made by one of the self-regulatory bodies cannot as such be referred to the Danish Medicines Agency. However, a dissatisfied party is not prevented from bringing a case before the Danish Medicines Agency even though it has already been before one of the self-regulatory bodies. In this case, the decision passed by the self-regulatory body will be taken into consideration when the Danish Medicines Agency assesses the case.

On 13 March 2007, the Danish Pharmaceutical Association and the Danish Medical Association, the Danish Association of the Pharmaceutical Industry and the Danish Association of Parallel Importers entered into a mutual agreement laying down rules on cooperation in the pharmaceutical area. At the same time, the parties also entered into an agreement on the principle of establishing a new common ethical board – the Pharmaceutical Area Self-Regulation Board. The board is to ensure compliance with the codes of practice on cooperation between the pharmaceutical industry and health professionals. The new ethical board is to begin its work on 1 January 2008 subject to adoption by the respective competent bodies of the parties to the agreement. The new cooperation agreement (the agreement on self-regulation) enters into force on 1 June 2007. The agreement combines in one mutual agreement, existing agreements between the Danish Association of the Pharmaceutical Industry, the Danish Medical Association and the Danish Pharmaceutical Association. At the same time, an update has been made, incorporating the most recent changes to the advertising rules. In the period leading to the establishment of the Pharmaceutical Area Self-Regulation Board, the Danish Board of Drug Advertising (Nævnet for Medicinsk Informationsmateriale), the Danish Board of Pharmacy Ethics (Apotekernes Etiske Nævn) and the Danish Medical Association Ethical Council (Lægeetisk Nævn), respectively, must ensure compliance with the cooperation agreement.

The Danish Board of Drug Advertising ensures that professional cooperation between health professionals and the pharmaceutical industry takes place according to the applicable rules, including the provisions comprised by the cooperation agreement with the Danish Medical Association and the Danish Pharmaceutical Association. The board assesses complaints and questions from health professionals and persons as well as companies affiliated to the Danish Association of the Pharmaceutical Industry, the Danish Industry Association for Generic Medicines, the Danish Association of Parallel Importers as well as the Medicine Wholesalers Association, complaints from public authorities, complaints from suppliers of medicinal products having entrusted their advertising material to the board, as well as complaints from others considered to have a special and commendable interest in the specific case.

The Danish Board of Drug Advertising may also open cases on its own initiative. Finally, the Danish Board of Drug Advertising can make a preliminary assessment of information material, etc. if a company that is subject to the board's competence so requests.

Advertising to the general public is outside the scope of the Danish Board of Drug Advertising.

Inquiries can be sent to the Danish Board of Drug Advertising, Strødamvej 50 A, DK-2100 Copenhagen Ø, or to the email address info@nmidk.dk.

The marketing board of VIF assesses complaints about the advertising activities of its members in the area of veterinary medicine.

Inquiries can be sent to the Marketing Board of the marketing board of VIF, Strødamvej 50 A, DK-2100 Copenhagen Ø, or to the email address vif@vif.dk.

12.4. Danish Board of Pharmacy Ethics (Apotekernes Etiske Nævn)

The Danish Board of Pharmacy Ethics ensures that professional cooperation between pharmacies and the pharmaceutical industry takes place according to the applicable rules, including the provisions comprised by the cooperation agreement (the agreement on self-regulation).

The Danish Board of Pharmacy Ethics assesses complaints from pharmacies, suppliers covered by the cooperation agreement, the Danish Board of Drug Advertising and others considered to have a special and commendable interest in the specific case. The board may also open cases on its own initiative.

12.5. Danish Medical Association Ethical Council (Lægeetisk Nævn)

The Danish Medical Association Ethical Council ensures that professional cooperation between doctors and the pharmaceutical industry takes place according to the applicable rules, including the provisions comprised by the cooperation agreement (the agreement on self-regulation).

The board assesses complaints and inquiries from medical organisations, members of the medical associations, the Danish Board of Drug Advertising and others considered to have a special and commendable interest in the specific case. The board may also open cases on its own initiative.

Inquiries can be sent to the Ethical Board of the Danish Medical Association Ethical Council (Lægeetisk Nævn), Trondhjemsgade 9, DK-2100 Copenhagen Ø.

12.6. The Ethical Board of the Danish Association of Suppliers to the Health Industry

The Ethical Board of the Danish Association of Suppliers to the Health Industry assesses advertising cases in breach of statutory rules and its own ethical code. The board can open cases on its own initiative, just as the board of directors of the Association of Suppliers to the Health Industry and its members may request it to assess a case.

The board can only assess cases pertaining to the members of the Danish Association of Suppliers to the Health Industry. However, the board can make statements in cases of principle, even in cases that have no direct connection to the members of the Danish Association of Suppliers to the Health Industry.

Inquiries can be sent to the Danish Association of Suppliers to the Health Industry, Børsen, DK-1217 Copenhagen K, or to the email address hbl@hts.dk.

13. Previous guidelines

These guidelines replace guidelines no. 166 of 5 October 1998 of the Danish Medicines Agency.